Cancer-related Venous Thromboembolism Clinical Trial
Official title:
Measurement of Adherence and Health-related Quality of Life, and Health-Care Resource Utilization During Anticoagulation Therapy in Cancer-Related Venous Thromboembolism (VTE)
The goal of this research study is to learn about the quality of life, experiences with treatment, and healthcare costs of patients who are receiving long-term treatment for venous thromboembolism (VTE) that is related to cancer. This is an investigational study. Up to 260 participants will be enrolled in this multicenter study. Up to 170 will take part in MD Anderson.
| Status | Recruiting |
| Enrollment | 260 |
| Est. completion date | December 31, 2026 |
| Est. primary completion date | December 31, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: 1. Adult (= 18 years) female or male subjects. 2. Confirmed symptomatic proximal or distal lower extremity deep venous thrombosis with or without pulmonary embolism or other venous thromboses. For a symptomatic lower extremity deep venous thrombosis confirmed by compression ultrasonography, venography, or specific computerized tomography (CT) venography, or a thrombus detected in the iliac veins on an abdominal or pelvic CT. For symptomatic pulmonary embolism confirmed by computerized tomographic pulmonary angiography, ventilation perfusion scan, or catheter pulmonary angiography. 3. Cancer (other than basal-cell or squamous-cell carcinoma of the skin), either active or diagnosed within 2 years prior to VTE. The diagnosis of cancer must be objectively documented by histopathologic diagnosis. 4. Intention for long-term treatment (at least 3 months) with anticoagulation. 5. Participants will be enrolled in the study within the first 72 hours from initiation of anticoagulation. 6. Able to provide informed consent and complete study survey tools 7. Able to read and speak English. Exclusion Criteria: 1. Indication for anticoagulation other than cancer-related VTE. 2. An Eastern Cooperative Oncology Group (ECOG) Performance Status of 4 at the time of study enrollment. 3. Life expectancy < 3 months. 4. Isolated pulmonary embolism, or isolated upper extremity deep venous thrombosis, or isolated splanchnic venous thrombosis, or isolated cerebral venous thrombosis confirmed by compression ultrasonography, venography, or CT. |
| Country | Name | City | State |
|---|---|---|---|
| Colombia | Fundacion Valle del Lili | Cali | |
| Spain | Hospital Clinic | Barcelona | Carrer De Villarroel, 170 |
| Spain | Hospital German Trias i Pujol | Barcelona, | |
| United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| M.D. Anderson Cancer Center |
United States, Colombia, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Self-Reported Adherence to Anticoagulation | Adherence categorized as "adequate" versus "non-adequate" based on the Morisky scale. | Baseline up to 6 months | |
| Secondary | HRQL Variables in Patients for Cancer-Related VTE Treated with Anticoagulation | The HRQL variables measured using a deep venous thrombosis quality of life questionnaire: DVTQOL. | Baseline, 3 months, and 6 months |